1266-P: Diabetes INSIDE: Improving Population HbA1c Testing and Targets in Primary Care with QI

This study assessed the relationship between FPG, PPG and glycated hemoglobin (A1C) target attainment using ADA glycemic targets in patients (pts) with T2D. A post-hoc analysis of the phase 3 LixiLan-O (NCT02058147) trial assessed the efficacy and safety of iGlarLixi (n=468) vs. insulin glargine U100 (iGlar) (n=466) and lixisenatide (Lixi) (n=233) in pts uncontrolled on metformin ± a second OAD, continuing only on metformin, over a 30-week period. The proportion of pts reaching both FPG and PPG target was highest for iGlarLixi, while the proportions of those reaching FPG or PPG targets only were highest for iGlar (targeting FPG) and Lixi (targeting PPG), respectively (Figure 1A). There was a stepwise trend in A1C change, end-of-study A1C, and proportion of pts reaching A1C goals in favor of iGlarLixi, followed by iGlar and Lixi (Figure 1B-D). Pts reaching both FPG and PPG targets had the greatest A1C drop and lowest A1C values, and represented the largest proportion of pts acheiving A1C target. No differences were observed in hypoglycemia rates in all treatment arms, and a greater proportion of pts experienced weight loss with iGlarLixi vs. iGlar (55.3% vs. 39.9%). By simultaneously targeting fasting and postprandial hyperglycemia, iGlarLixi treatment results in greater A1C reduction and better A1C target attainment than iGlar or Lixi alone. Disclosure C. Desouza: Consultant; Self; Novo Nordisk A/S, Sanofi. Research Support; Self; Merck & Co., Inc.. Advisory Panel; Self; Medscape. V. Fonseca: Consultant; Self; Abbott. Board Member; Self; American Association of Clinical Endocrinologists. Consultant; Self; Eli Lilly and Company. Stock/Shareholder; Self; Amgen Inc.. Consultant; Self; Asahi Kasei Corporation, AstraZeneca, Novo Nordisk Inc., ADOCIA, Intarcia Therapeutics, Inc., Sanofi-Aventis. J.P. Frias: Research Support; Self; AbbVie Inc., Allergan, Amgen Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Bristol-Myers Squibb Company. Consultant; Self; CeQur Corporation. Research Support; Self; Cirius Therapeutics, AstraZeneca, Calibra Medical, Elcelyx Therapeutics, Inc.. Consultant; Self; Elcelyx Therapeutics, Inc.. Research Support; Self; Eli Lilly and Company, Genentech, Inc., Ionis Pharmaceuticals, Inc., ICON plc., Janssen Pharmaceuticals, Inc.. Consultant; Self; Johnson & Johnson Diabetes Institute, LLC.. Research Support; Self; Lexicon Pharmaceuticals, Inc., Ligand Pharmaceuticals, Inc.. Consultant; Self; Ligand Pharmaceuticals, Inc.. Research Support; Self; Merck & Co., Inc., Novartis Pharmaceuticals Corporation, Novo Nordisk Inc., Pfizer Inc., Sanofi. Consultant; Self; Sanofi. Speaker's Bureau; Self; Sanofi. Research Support; Self; Theracos, Inc. L. Van Gaal: Advisory Panel; Self; Astra Zeneca, Boehringer Ingelheim, Eli Lilly, Janssen J & J, Merck MSD, Novo Nordisk, Sanofi and Servier/Intarcia. Speaker's Bureau; Self; Astra Zeneca, Boehringer Ingelheim, Eli Lilly, Janssen J & J, Merck MSD, Novo Nordisk, Sanofi and Servier/Intarcia. Research Support; Self; EU (Hepadip & Resolve consortium) and National Research Funds. F. Giorgino: Consultant; Self; Abbott, AstraZeneca, Boehringer Ingelheim GmbH. Research Support; Self; Eli Lilly and Company, Johnson & Johnson Services, Inc.. Consultant; Self; MedImmune, Merck Sharp & Dohme Corp., Roche Diabetes Care Health and Digital Solutions, Sanofi. Research Support; Self; Takeda Development Centre Europe Ltd.. J. Chao: None. T.A. Dex: Employee; Self; Sanofi US. Stock/Shareholder; Self; Pfizer Inc., Merck Sharp & Dohme Corp., Teva Pharmaceutical Industries Ltd.. M. Roberts: None. A. Saremi: Employee; Self; Sanofi US. L.A. Leiter: Advisory Panel; Self; AstraZeneca. Research Support; Self; AstraZeneca. Speaker's Bureau; Self; AstraZeneca. Advisory Panel; Self; Boehringer Ingelheim Pharmaceuticals, Inc.. Research Support; Self; Boehringer Ingelheim Pharmaceuticals, Inc.. Speaker's Bureau; Self; Boehringer Ingelheim Pharmaceuticals, Inc.. Advisory Panel; Self; Eli Lilly and Company. Speaker's Bureau; Self; Eli Lilly and Company. Research Support; Self; GlaxoSmithKline plc.. Advisory Panel; Self; Janssen Pharmaceuticals, Inc.. Research Support; Self; Janssen Pharmaceuticals, Inc.. Speaker's Bureau; Self; Janssen Pharmaceuticals, Inc.. Advisory Panel; Self; Merck & Co., Inc.. Speaker's Bureau; Self; Merck & Co., Inc.. Research Support; Self; Merck & Co., Inc.. Advisory Panel; Self; Novo Nordisk Inc.. Research Support; Self; Novo Nordisk Inc.. Speaker's Bureau; Self; Novo Nordisk Inc.. Advisory Panel; Self; Sanofi. Research Support; Self; Sanofi. Speaker's Bureau; Self; Sanofi. Advisory Panel; Self; Servier. Speaker's Bureau; Self; Servier. Research Support; Self; Servier. Advisory Panel; Self; Amgen Inc.. Speaker's Bureau; Self; Amgen Inc.. Research Support; Self; Amgen Inc., Esperion Therapeutics, Kowa Pharmaceuticals America, Inc., The Medicines Company. Advisory Panel; Self; Akcea Therapeutics, Novartis Pharmaceuticals Corporation.

This real-world retrospective observational analysis was conducted using data from REACHnet, a U.S. regional electronic medical records (EMR) database. Glycemic outcomes after simultaneous or sequential initiation of basal insulin (BI) and a glucagon-like peptide-1 receptor agonist (GLP-1 RA) were evaluated in patients with T2D uncontrolled (A1C ≥7.0%) on oral antidiabetes drugs (OADs). Three patient cohorts were defined: simultaneous BI and GLP-1 RA initiation (Cohort 1; n=109); initiation of BI followed by a GLP-1 RA with a gap of ≤90 days (Cohort 2; n=301); and initiation of BI followed by a GLP-1 RA with a gap of >90 days (Cohort 3; n=459). Baseline mean A1C was very similar across the cohorts (10.3%, 10.3%, and 10.2% in Cohorts 1, 2, and 3, respectively), as were comorbidities including dyslipidemia, hypertension, and obesity. Mean A1C decreased in all 3 cohorts in the 12 months from the date of first BI injection. The greatest mean A1C reductions occurred within 6 months of simultaneous administration (Cohort 1: -2.18%), followed by addition of a GLP-1 RA within 90 days (Cohort 2: -1.77%) and after 90 days (Cohort 3: -1.24%). Results at 12 months were Cohort 1: -1.66%; Cohort 2: -1.46%; and Cohort 3: -1.32%. Persistence (i.e., non-discontinuation of index treatments) at 12 months was 74.3%, 73.8%, and 80.0% in Cohorts 1, 2, and 3, respectively. Simultaneous initiation resulted in more patients achieving A1C <7.0% at 12 months (33.4%, 24.5%, and 20.9% in Cohorts 1, 2, and 3, respectively); data were statistically significant different between Cohorts 1 and 3 (p=0.0186), but not between Cohorts 1 and 2 or Cohorts 2 and 3. In conclusion, this retrospective analysis of real-world EMR data in patients with T2D uncontrolled on OADs suggests that simultaneous initiation of BI and a GLP-1 RA resulted in significantly better glycemic control than sequential initiation with a gap of >90 days. Disclosure X.V. Peng: Employee; Self; Sanofi. Stock/Shareholder; Spouse/Partner; AbbVie Inc. Stock/Shareholder; Self; AbbVie Inc., Sanofi. R. Ayyagari: Consultant; Self; Sanofi US. Other Relationship; Self; Various pharmaceutical companies. R. Lubwama: Employee; Self; Merck & Co., Inc., Sanofi. M.J. Van Vleet: Employee; Self; Sanofi US. L. Shi: None. E.G. Price-Haywood: None. P. Hollander: Advisory Panel; Self; Novo Nordisk Inc. V. Fonseca: Board Member; Self; American Association of Clinical Endocrinologists. Consultant; Self; Abbott, Asahi Kasei Corporation, Novo Nordisk Inc., Sanofi US, Takeda Pharmaceutical Company Limited. Research Support; Self; Bayer US. Stock/Shareholder; Self; Amgen Inc., BRAVO4HEALTH, Mellitus Health. Funding Sanofi U.S.

Background: Understanding the long-term cardiovascular safety of type 2 diabetes (T2D) medications is a high-priority research area. We used electronic medical record (EMR) data in the National Patient Centered Clinical Research Network (PCORnet) to characterize “real-world” use of T2D medications. Methods and Results: We identified a retrospective cohort of patients with T2D using a validated computable phenotype. We queried 4 unique PCORnet sites for data regarding T2D medication use in the 90 days before and after cohort entry. We described patient demographics, comorbidities, non-T2D medication use, and clinical variables in the 730 days prior to cohort entry. We identified 49,654 patients with T2D across the 4 sites (range: 2,276-20,322). Use of T2D medications, characterized by pharmacologic class, and selected characteristics are presented in Table. Among patients prescribed a single class of T2D medication, metformin was the most common (52.5%). Among patients prescribed multiple classes of T2D agents, the most common combination was metformin and sulfonylureas (49%). Conclusions: Across 4 PCORnet sites, metformin-based regimens were very prevalent, and approximately 10% of regimens included newer agents. PCORnet will be a valuable resource for future observational studies of T2D medications and long-term cardiovascular outcomes in “real-world” populations. Disclosure K.N. Bachmann: Stock/Shareholder; Self; Medtronic. C. Roumie: None. A.D. Wiese: None. C.G. Grijalva: None. J.B. Buse: Consultant; Self; Neurimmune AG. Research Support; Self; AstraZeneca, National Center for Advancing Translational Sciences, National Institute of Diabetes and Digestive and Kidney Diseases, Novo Nordisk A/S, Sanofi, vTv Therapeutics. Stock/Shareholder; Self; Mellitus Health, PhaseBio Pharmaceuticals, Inc., Stability Health. Other Relationship; Self; ADOCIA, AstraZeneca, Dance Biopharm Holdings Inc., Eli Lilly and Company, MannKind Corporation, NovaTarg, Novo Nordisk A/S, Senseonics, vTv Therapeutics, Zafgen, Inc. R. Bradford: None. E.O. Zalimeni: None. P. Knoepp: None. H.L. Morris: None. W.T. Donahoo: None. N. Fanous: None. V. Fonseca: Board Member; Self; American Association of Clinical Endocrinologists. Consultant; Self; Abbott, Asahi Kasei Corporation, Novo Nordisk Inc., Sanofi US, Takeda Pharmaceutical Company Limited. Research Support; Self; Bayer US. Stock/Shareholder; Self; Amgen Inc., BRAVO4HEALTH, Mellitus Health. B. Katalenich: None. M.M. Cook: None. R.L. Rothman: Consultant; Self; Abbott, edlogics. R.J. Chakkalakal: None. Funding National Institutes of Health (UL1TR002489, UL1TR002489); U.S. Department of Veterans Affairs (IK2CX001678); Patient-Centered Outcomes Research Institute (CDRN-1306-04869)

We have successfully implemented the ADA’s Diabetes INSIDE® QI program at a University hospital and safety-net health system (Tulane and Parkland), focused on system-wide improvement in poorly controlled type 2 diabetes (A1c>8.0%). We extrapolated clinical outcomes of the QI program on a 5-year risk of complications, utilizing a validated risk prediction model: Building, Relating, Assessing, Validating of Outcomes (BRAVO) simulation model. We measured the differences between the baseline and post-intervention values of risk factors in 2,429 individuals with A1c >8% at baseline and used the BRAVO model to project the 5-year risk reduction of diabetes-related complications under the assumption that intervention benefits diminished with time. The intervention period was defined as one year and the post-intervention period as the subsequent six months. The QI program was associated with reductions in A1c (-0.84%) and LDL-C (-5.94 mg/dl) among individuals with A1c level >8.0%, with greater reduction in A1c (-1.67%) and LDL-C (-6.81 mg/dl) among those with A1c level > 9.5% at baseline (all p<0.05). The potential outcome of the QI program on 5-year risk of complications are presented in Fig 1. Our outcomes model suggests that the observed risk factor reduction is projected to lead to clinically significant 5-year risk of events - benefiting patients and population health as it relates to future complications burden." Disclosure H. Shao: None. L. Shi: None. R.E. Furman: None. L. Meneghini: Advisory Panel; Self; AstraZeneca, Novo Nordisk Inc., Sanofi-Aventis. Consultant; Self; Sanofi-Aventis. Other Relationship; Self; American Diabetes Association. T.S. Harlan: None. V. Fonseca: Board Member; Self; American Association of Clinical Endocrinologists. Consultant; Self; Abbott, Asahi Kasei Corporation, Novo Nordisk Inc., Sanofi US, Takeda Pharmaceutical Company Limited. Research Support; Self; Bayer US. Stock/Shareholder; Self; Amgen Inc., Bravo4health, Mellitus Health. Funding Lilly USA, LLC; Novo Nordisk; Sanofi

To evaluate the clinical utility of Glycated Albumin (GA) as an intermediate-term marker of glycemic control (preceding 2-3 weeks), we compared the correlation and concordance of GA and fructosamine (FRA) with A1C and mean blood glucose (MBG) measurements. One hundred fifty subjects with type 1 (n=73) and type 2 diabetes (n=77) were assigned to Group 1 (n=98, A1C ≥7.5%, prescribed a change in diabetes therapy) and Group 2 (n=52, A1C <7.5%, remained on stable diabetes therapy). Fasting plasma glucose, GA, FRA, and A1C were measured at 0, 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 weeks. MBG was calculated using weekly 7-point self-monitored blood glucose (SMBG) profiles throughout the study. Continuous glucose monitoring (CGM) was conducted on 30 participants to confirm the accuracy of MBG calculated by SMBG. Across all subjects, GA correlation with FRA was 0.920; the minimum correlation was 0.863. The estimated mean correlations of GA with A1C and MBG were greater than that of FRA as estimated by mean Pearson correlations using the method of Lorenz. The within-subject correlation between GA and FRA was 0.643 and the correlations for GA with A1C and MBG were significantly greater than those observed for FRA (0.585 vs. 0.395 for A1C p<0.001; 0.548 vs. 0.413 for MBG, p<0.001). To further examine the concordance of GA and FRA with A1C and MBG, a comparison of the Pearson correlations demonstrated that in 56% of subjects GA had a higher correlation with both A1C and MBG than FRA, compared to only 4% of subjects where FRA had higher correlations with both. Overall, GA had a higher Pearson correlation with A1C and MBG in 82% and 70% of subjects, respectively. In conclusion, GA may be a more useful diagnostic test than FRA in clinical situations requiring measurement of intermediate-term glycemic control. Disclosure C. Desouza: Consultant; Self; Novo Nordisk A/S, Sanofi. Research Support; Self; Merck & Co., Inc.. Advisory Panel; Self; Medscape. J. Rosenstock: Advisory Panel; Self; Eli Lilly and Company. Consultant; Self; Eli Lilly and Company. Research Support; Self; Novo Nordisk Inc.. Consultant; Self; Novo Nordisk Inc.. Advisory Panel; Self; Sanofi. Consultant; Self; Sanofi. Advisory Panel; Self; Janssen Pharmaceuticals, Inc.. Consultant; Self; Janssen Pharmaceuticals, Inc.. Advisory Panel; Self; Boehringer Ingelheim Pharmaceuticals, Inc.. Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc.. Advisory Panel; Self; Intarcia Therapeutics, Inc.. Consultant; Self; Intarcia Therapeutics, Inc.. Research Support; Self; Merck & Co., Inc., Pfizer Inc., Sanofi, Novo Nordisk Inc., Bristol-Myers Squibb Company, Eli Lilly and Company, Intarcia Therapeutics, Inc., Genentech, Inc. J.P. Frias: Research Support; Self; AbbVie Inc., Allergan, Amgen Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Bristol-Myers Squibb Company. Consultant; Self; CeQur Corporation. Research Support; Self; Cirius Therapeutics, AstraZeneca, Calibra Medical, Elcelyx Therapeutics, Inc.. Consultant; Self; Elcelyx Therapeutics, Inc.. Research Support; Self; Eli Lilly and Company, Genentech, Inc., Ionis Pharmaceuticals, Inc., ICON plc., Janssen Pharmaceuticals, Inc.. Consultant; Self; Johnson & Johnson Diabetes Institute, LLC.. Research Support; Self; Lexicon Pharmaceuticals, Inc., Ligand Pharmaceuticals, Inc.. Consultant; Self; Ligand Pharmaceuticals, Inc.. Research Support; Self; Merck & Co., Inc., Novartis Pharmaceuticals Corporation, Novo Nordisk Inc., Pfizer Inc., Sanofi. Consultant; Self; Sanofi. Speaker's Bureau; Self; Sanofi. Research Support; Self; Theracos, Inc. S. Hsia: Research Support; Self; Tobira Therapeutics, AstraZeneca, Bayer AG, Cirius Therapeutics, Eli Lilly and Company, Intarcia Therapeutics, Inc., Ionis Pharmaceuticals, Inc., Ligand Pharmaceuticals, Inc., Merck & Co., Inc., National Institute of General Medical Sciences, PhaseBio Pharmaceuticals, Inc., Sanofi-Aventis, TaiwanJ Pharmaceuticals Co., Ltd., Theracos, Inc., VTV Therapeutics, Bristol-Myers Squibb Company. L.C. Myers: Speaker's Bureau; Self; AstraZeneca, Novo Nordisk Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Sanofi-Aventis. E.J. Klein: None. R. Zhou: None. T. Kohzuma: Employee; Self; Asahi Kasei Corporation. V. Fonseca: Consultant; Self; Abbott. Board Member; Self; American Association of Clinical Endocrinologists. Consultant; Self; Eli Lilly and Company. Stock/Shareholder; Self; Amgen Inc.. Consultant; Self; Asahi Kasei Corporation, AstraZeneca, Novo Nordisk Inc., ADOCIA, Intarcia Therapeutics, Inc., Sanofi-Aventis.

Objective: Several Cardiovascular Outcome Trials (CVOTs) have demonstrated benefits compared to placebo. However, the patients included were heterogeneous, including several with long duration diabetes, insulin treatment may be a surrogate for duration and severity of disease. We conducted a meta-analysis to evaluate the impact of concurrent insulin treatment on the odds of meeting the primary outcome in recent CVOTs. Methods: PubMed and google scholar were searched for CVOTs with new drugs for diabetes. We found 10 publications, of which 7 provided outcomes according to insulin use. We compared the risk ratio of the primary endpoint in the group taking insulin with those not taking insulin by extracting the number of events in both groups along with total number of patients. We also removed the 2 trials that used dipeptidyl peptidase 4 inhibitors, since none of the drugs had shown benefit in the trials. The I-square was used to assess between-study heterogeneity and all analyses were performed using STATA program version 15.1. Fixed effect models were used in these analyses due to low heterogeneity. This study was conducted in compliance with PRISMA guidelines. Results: When all 7 trials were included in the meta-analysis (EXSCEL, SUSTAIN6, SAVORTIMI, EMPAREG, LEADER, EXAMINE, and DECLARE), the risk ratio of the primary outcome was significantly increased indicating that patients using insulin with drug are more likely to have the primary cardiovascular outcome than the group of patients using drug without insulin. The RR was 1.43 (95% confidence interval: 1.32, 1.55). Conclusion: In recent CVOTs which have demonstrated a benefit of the study drug on the primary outcome compared to usual care, the concomitant use of Insulin along with the study drugs led to a higher risk of cardiovascular events than in patients who were on the drugs without insulin. The reason for this increased risk is unclear but may be related to the likely longer duration of diabetes and poorer antecedent control which led to the use of insulin. Disclosure J. Khatib: None. Y. Shao: None. L. Shi: None. V. Fonseca: Board Member; Self; American Association of Clinical Endocrinologists. Consultant; Self; Abbott, Asahi Kasei Corporation, Novo Nordisk Inc., Sanofi US, Takeda Pharmaceutical Company Limited. Research Support; Self; Bayer US. Stock/Shareholder; Self; Amgen Inc., BRAVO4HEALTH, Mellitus Health.

We have previously described the utility and high predictive value of the Building, Relating, Assessing, and Validating Outcomes (BRAVO) model, which was developed from the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial data. However, it uses diabetes duration as a key factor for modelling diabetes progression, and diabetes duration is not routinely collected in EMRs. This study use machine learning to estimate diabetes duration with EMR information. Among individuals (N=8,026) with complete records from the ACCORD trial, diabetes duration was estimated with an ordinary least squares (OLS) model, a least absolute shrinkage and selection operator (LASSO) model, a pruned decision tree model, and a random forest model using 37 baseline predictors such as biomarkers, demographics, disease history, and medications. Model performance was compared using root-mean-square Error (RMSE), mean-absolute error (MAS), and R-squared. All three indicators were calculated through 10-fold cross-validation with 1000 iterations in order to address over-fitting. Age, current HbA1c value, retinopathy, number of oral antidiabetic drugs, number of Insulin types, and use of sulfonylureas were identified as key predictors for patient-reported diabetes duration. The random forest model achieved the best performance on all three indicators (RMSE=6.16, MAE= 4.71, R2=0.30), significantly higher than the pruned decision tree model (RMSE=6.57, MAE= 5.03, R2=0.21) and LASSO model (RMSE=6.60, MAE= 5.08, R2=0.20). Diabetes duration can be predicted using fields routinely included in EMRs. Integration of the results of this prediction equation into predictive diabetes models (such as BRAVO) will allow patient-specific estimates of diabetes duration based solely on EMRs. This will increase precision when inferring risk level and using models to aid clinical decision making among patients with type 2 diabetes. Disclosure H. Shao: None. S. Yang: None. C. Stoecker: None. V. Fonseca: Board Member; Self; American Association of Clinical Endocrinologists. Consultant; Self; Abbott, Asahi Kasei Corporation, Novo Nordisk Inc., Sanofi US, Takeda Pharmaceutical Company Limited. Research Support; Self; Bayer US. Stock/Shareholder; Self; Amgen Inc., BRAVO4HEALTH, Mellitus Health. X. Cheng: None. L. Shi: None.

Treatments that reduce A1C levels often do not reflect improvements in both fasting and postprandial hyperglycemia. Data from 731 patients (pts) with T2D uncontrolled on basal insulin ± OADs in the LixiLan-L trial (NCT02058160) were used to investigate the association between achieving FPG/PPG targets and A1C target attainment after 30 weeks of treatment with iGlarLixi (n=366) or iGlar (n=365). Outcomes were A1C target attainment, A1C change from baseline, and mean A1C at Week 30 in pts achieving both FPG and PPG target, FPG target only, PPG target only, or neither, using ADA glycemic targets. The proportion of pts reaching PPG only, or both FPG and PPG target, was numerically higher for iGlarLixi, while the proportion reaching FPG target only was numerically higher for iGlar (Figure. 1A). iGlarLixi-treated pts reaching both FPG and PPG targets, or FPG target only, showed statistically significant greater A1C changes from baseline, lower end-of-trial A1C, and a higher proportion reaching A1C target than iGlar-treated pts (Figure. 1B-D). Despite a numerically higher proportion of pts reaching FPG target only in the iGlar arm, A1C outcomes were in favor of pts receiving iGlarLixi. In conclusion, the complementary actions of iGlarLixi on both fasting and postprandial hyperglycemia were associated with better A1C target attainment compared with iGlar alone, which mainly targets fasting hyperglycemia. Disclosure L.A. Leiter: Advisory Panel; Self; AstraZeneca. Research Support; Self; AstraZeneca. Speaker's Bureau; Self; AstraZeneca. Advisory Panel; Self; Boehringer Ingelheim Pharmaceuticals, Inc.. Research Support; Self; Boehringer Ingelheim Pharmaceuticals, Inc.. Speaker's Bureau; Self; Boehringer Ingelheim Pharmaceuticals, Inc.. Advisory Panel; Self; Eli Lilly and Company. Speaker's Bureau; Self; Eli Lilly and Company. Research Support; Self; GlaxoSmithKline plc.. Advisory Panel; Self; Janssen Pharmaceuticals, Inc.. Research Support; Self; Janssen Pharmaceuticals, Inc.. Speaker's Bureau; Self; Janssen Pharmaceuticals, Inc.. Advisory Panel; Self; Merck & Co., Inc.. Speaker's Bureau; Self; Merck & Co., Inc.. Research Support; Self; Merck & Co., Inc.. Advisory Panel; Self; Novo Nordisk Inc.. Research Support; Self; Novo Nordisk Inc.. Speaker's Bureau; Self; Novo Nordisk Inc.. Advisory Panel; Self; Sanofi. Research Support; Self; Sanofi. Speaker's Bureau; Self; Sanofi. Advisory Panel; Self; Servier. Speaker's Bureau; Self; Servier. Research Support; Self; Servier. Advisory Panel; Self; Amgen Inc.. Speaker's Bureau; Self; Amgen Inc.. Research Support; Self; Amgen Inc., Esperion Therapeutics, Kowa Pharmaceuticals America, Inc., The Medicines Company. Advisory Panel; Self; Akcea Therapeutics, Novartis Pharmaceuticals Corporation. J. Chao: None. A. Saremi: Employee; Self; Sanofi US. T.A. Dex: Employee; Self; Sanofi US. Stock/Shareholder; Self; Pfizer Inc., Merck Sharp & Dohme Corp., Teva Pharmaceutical Industries Ltd. J.A. Davidson: Other Relationship; Self; American Association of Clinical Endocrinologists. Consultant; Self; Aspire Bariatrics. Advisory Panel; Self; AstraZeneca. Consultant; Self; Boston Therapeutics, Inc.. Advisory Panel; Self; GlaxoSmithKline plc., Intarcia Therapeutics, Inc., Merck & Co., Inc., Janssen Pharmaceuticals, Inc., Novo Nordisk A/S, Sanofi.

Hypoglycemia (HYPO) is a major barrier in achieving optimal glycemic control in T1D. Intensifying insulin therapy to lower HbA1c is frequently accompanied by an increased risk of HYPO. In two 52-week phase 3 studies (inTandem1 and 2), sotagliflozin (SOTA), a dual SGLT1 and 2 inhibitor as adjunct to optimized insulin therapy, demonstrated significant reduction in HbA1c and body weight without increasing the risk of severe hypoglycemia compared with placebo (PBO) in adults with T1D. To further evaluate the HYPO profile of SOTA added to insulin, we analyzed rates of confirmed HYPO (level 1, glucose ≤70 mg/dL in the study) and clinically important HYPO (level 2, glucose ≤55 mg/dL in the study) in a patient-level pooled analysis (n=1,368) using a negative binomial model adjusted for HbA1c at week 52. Rates of level 1 HYPO events per patient year were 99.48, 77.14, and 77.14 for PBO, SOTA 200mg, and 400mg, respectively (P<0.0001 vs. PBO for both doses). Significantly lower rates (P<0.0001 vs. PBO for both doses) of level 2 HYPO were also observed (19.69, 14.22, and 13.86 for PBO, SOTA 200mg, and 400mg, respectively). HYPO rate reduction was more pronounced at lower HbA1c with SOTA vs. PBO (Figure). In conclusion, at week 52 overall level 1 and 2 HYPO event rates were 22.5-30% lower with SOTA when used as adjunct to optimized insulin therapy vs. PBO and were reduced at any HbA1c level especially at lower HbA1c values. Disclosure T. Danne: Advisory Panel; Self; Abbott, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Lilly Diabetes, Medtronic, Novo Nordisk A/S, Roche Diabetes Care, Sanofi-Aventis. Speaker's Bureau; Self; Dexcom, Inc. J. Pettus: Advisory Panel; Self; Diasome Pharmaceuticals, Inc., Lilly Diabetes, Novo Nordisk Inc., Sanofi. Speaker's Bureau; Self; MannKind Corporation. A. Giaccari: Advisory Panel; Self; Sanofi. Board Member; Self; Novo Nordisk A/S. Speaker's Bureau; Self; Amgen Inc., AstraZeneca, Merck Sharp & Dohme Corp., Sanofi. B. Cariou: Board Member; Self; Novo Nordisk A/S, Regeneron Pharmaceuticals. Consultant; Self; GENFIT, Sanofi-Aventis. Research Support; Self; Amgen Inc., Pfizer Inc. Speaker's Bureau; Self; Abbott, Akcea Therapeutics, Merck Sharp & Dohme Corp. H.W. Rodbard: Advisory Panel; Self; Bayer US, Janssen Pharmaceuticals, Inc., Lexicon Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk Inc., Sanofi. Consultant; Spouse/Partner; Eli Lilly and Company. Consultant; Self; Gan & Lee Pharmaceuticals. Research Support; Self; Lexicon Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi. Speaker's Bureau; Self; Merck & Co., Inc., Novo Nordisk Inc. S.A. Weinzimer: Consultant; Self; Eli Lilly and Company, Sanofi. Consultant; Spouse/Partner; Tandem Diabetes Care. Consultant; Self; Zealand Pharma A/S. Speaker's Bureau; Self; Insulet Corporation, Medtronic MiniMed, Inc., Tandem Diabetes Care. Stock/Shareholder; Self; InsuLine Medical Ltd. M. Bonnemaire: Employee; Self; Sanofi. S. Sawhney: Stock/Shareholder; Spouse/Partner; AstraZeneca, Gilead Sciences, Inc., GlaxoSmithKline plc., Merck & Co., Inc., Pfizer Inc. S. Wang: Employee; Self; Sanofi US. R. Castro: Employee; Self; Sanofi US. S.K. Garg: Advisory Panel; Self; Eli Lilly and Company, Roche Pharma, Sanofi-Aventis, Zealand Pharma A/S. Research Support; Self; Eli Lilly and Company, WebMD. Funding Lexicon Pharmaceuticals Inc.; Sanofi

Aim: To examine the efficacy of 12 weeks of monthly evolocumab (EvoMab) 420 mg vs. placebo (Pbo) in lowering LDL-C in those with type 2 diabetes mellitus (T2DM) and hypercholesterolemia or mixed dyslipidemia and on statin therapy. Methods: Patients ≥18 years with T2DM, HbA1c <10%, on stable pharmacotherapy for diabetes for ≥6 months, and taking a statin were eligible; 421 were randomized (2:1 EvoMab:Pbo) and dosed. Co-primary endpoints: mean % change in LDL-C from baseline to week 12 and mean % change in LDL-C from baseline to the mean of weeks 10 and 12. Additional measures included change in non-HDL-C, LDL-C goals, and measures of glycemic control. Results: Mean participant age (SD) was 62 (8) years; 44% women; 77% Caucasian. In modified, intent to treat analyses (all randomized and dosed patients) EvoMab significantly reduced LDL-C and non-HDL-C vs. Pbo, and did not impact glycemic control. The incidence of AEs was comparable between EvoMab and Pbo, with no clinically meaningful differences in serious AEs. See Table.Table.Placebo(N=141)Evolocumab(N=280)Baseline LDL-C (mg/dL), mean (SD)110.4 (33.0)108.6 (31.0)Baseline non-HDL-C (mg/dL), mean (SD)145.5 (33.9)144.6 (34.9)Any adverse event (AE), n (%)52 (36.9)110 (39.3)Serious AE, n (%)2 (1.4)14 (5.0) 14 (5.0)14 (5.0)aMean of Weeks 10 and 12LipidsPercent change from baseline in LDL-C, mean (SE)–0.8 (1.8)–65.0 (1.3)bPercent change from baseline in non-HDL-C, mean (SE)–0.(1.6)–56.6 (1.2)bAchievement of LDL-C < 70 mg/dL, n, %20 (14.8)253 (92.7)bAchievement of ≥50% reduction in LDL-C, n, %1 (0.7)230 (84.2)bWeek 12Glycemic ControlChange from baseline in FSG in mg/dL, median (Q1, Q3)4.0(–15.0, 29.0)5.0(–13.5, 29.5)Change from baseline in HbA1c in percent, median (Q1, Q3)0.1(–0.2, 0.5)0.1(–0.2, 0.5)aNo pattern in differences in serious AEs was observed. Chronic obstructive pulmonary disease was the only serious AE reported by ≥ 1% of patients in the evolocumab treatment group.bP < 0.0001 for evolocumab versus placebo comparisonFSG, fasting serum glucose; HbA1c, glycated hemoglobin; LDL-C, low-density lipoprotein cholesterol; non-HDL-C, non-high-density lipoprotein cholesterol; SE, standard errorFunding: Amgen Inc. Conclusion: In statin-treated patients with T2DM and hypercholesterolemia or mixed dyslipidemia, evolocumab safely and effectively lowered LDL-C. Disclosure R.S. Rosenson: Other Relationship; Self; Akcea Therapeutics, Amgen Inc., AstraZeneca, Eli Lilly and Company, The Medicines Company, Regeneron Pharmaceuticals, Inc., Sanofi US, Kowa Pharmaceuticals America, Inc., UpToDate. M.L. Daviglus: Advisory Panel; Self; Amgen Inc. P. Reaven: Research Support; Self; AstraZeneca, Amgen Inc., Bristol-Myers Squibb Company. P. Pozzilli: Research Support; Self; Sanofi. Speaker's Bureau; Self; Eli Lilly and Company. Research Support; Self; Merck Sharp & Dohme Corp. H. Bays: Research Support; Self; Amgen Inc. M. Monsalvo: Employee; Self; Amgen Inc.. Stock/Shareholder; Self; Amgen Inc. M. Elliott: Employee; Self; Amgen Inc.. Stock/Shareholder; Self; Amgen Inc. R. Somaratne: Employee; Self; NGM Biopharmaceuticals. Stock/Shareholder; Self; NGM Biopharmaceuticals. Y. Handelsman: Consultant; Self; Amarin Corporation. Speaker's Bureau; Self; Amarin Corporation. Board Member; Self; American Association of Clinical Endocrinologists. Consultant; Self; Amgen Inc.. Research Support; Self; Amgen Inc.. Speaker's Bureau; Self; Amgen Inc.. Consultant; Self; AstraZeneca. Research Support; Self; AstraZeneca. Speaker's Bureau; Self; AstraZeneca. Research Support; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Bristol-Myers Squibb Company, Gan & Lee Pharmaceuticals. Consultant; Self; Intarcia Therapeutics, Inc., Janssen Pharmaceuticals, Inc.. Speaker's Bureau; Self; Janssen Pharmaceuticals, Inc.. Research Support; Self; Lexicon Pharmaceuticals, Inc.. Consultant; Self; Merck & Co., Inc.. Research Support; Self; Merck & Co., Inc.. Consultant; Self; Novo Nordisk Inc.. Research Support; Self; Novo Nordisk Inc.. Speaker's Bureau; Self; Novo Nordisk Inc., Regeneron Pharmaceuticals, Inc.. Consultant; Self; Sanofi. Research Support; Self; Sanofi. Speaker's Bureau; Self; Sanofi.

Background: Sixty percent of patients with T2DM on basal insulin have an A1C ≥7%. This study aimed to understand patient and HCP views of “control,” as this may impact how many patients reach an A1C<7%. Methods: A cross-sectional, web-based survey of 500 HCPs (primary care physicians, endocrinologists, nurse practitioners/physician assistants) and 618 adults with T2DM using basal insulin was conducted to assess perceptions, attitudes and behaviors associated with T2DM management. The survey was developed based on feedback from focus groups and piloted. Patients self-reported A1C and were asked to confirm the value with their HCP, if necessary. Results: Patients and HCPs differed on what it meant to be “in control.” A1C was used most often, but more frequently selected by HCPs (91% vs. 69%), followed by daily blood glucose meter readings (63% HCPs vs. 68% patients). Beyond A1C and daily blood glucose, patients most frequently used behavioral criteria (e.g., adherence to lifestyle changes and/or treatment regimens); HCPs most frequently used clinical criteria (e.g., hypoglycemia). The timeframe for defining control varied among patients, with those at A1C>8% more frequently reporting “the current moment” or “the past week.” Most HCPs focused on the last 3 months to define control (67% vs. 34% all patients, p<0.05). Patients also differed from HCPs regarding responsibility, being more likely to agree that controlling their diabetes is completely their (patients’) responsibility (34% HCPs vs. 67% patients, p<0.05). HCPs were more likely to agree that they (HCPs) have a responsibility to actively contribute to the control of their patients’ T2DM (90% vs. 60%, p<0.05). Conclusions: Patients with T2D in the U.S. have differing views from HCPs on key aspects of diabetes control and management, and are less likely to consider A1C value as a criterion for determining control. Recognizing these differences may improve communication, with the potential to improve patient outcomes. Disclosure M. Brod: Consultant; Self; Novo Nordisk A/S. K.J. Tomaszewski: Research Support; Self; Novo Nordisk Inc. A. Allen: Research Support; Self; Novo Nordisk Inc. D.F. Kruger: Research Support; Self; Dexcom, Inc.. Speaker's Bureau; Self; Dexcom, Inc.. Stock/Shareholder; Self; Dexcom, Inc.. Consultant; Self; Novo Nordisk Inc.. Speaker's Bureau; Self; Novo Nordisk Inc.. Research Support; Self; Novo Nordisk Inc.. Speaker's Bureau; Self; Eli Lilly and Company, Boehringer Ingelheim Pharmaceuticals, Inc.. Consultant; Self; Intarcia Therapeutics, Inc., Abbott. Research Support; Self; Sanofi. Consultant; Self; Sanofi. Research Support; Self; JAEB Center For Health Research. Consultant; Self; Janssen Pharmaceuticals, Inc.. Speaker's Bureau; Self; Janssen Pharmaceuticals, Inc.. Consultant; Self; AstraZeneca. Speaker's Bureau; Self; AstraZeneca. Research Support; Self; Hygieia, Lexicon Pharmaceuticals, Inc., National Institute of Diabetes and Digestive and Kidney Diseases. Speaker's Bureau; Self; Valeritas, Inc., Insulet Corporation. Consultant; Self; Insulet Corporation. Research Support; Self; Insulet Corporation. Consultant; Self; Merck & Co., Inc. M.K. Heile: Advisory Panel; Self; Novo Nordisk Inc.. Speaker's Bureau; Self; Novo Nordisk Inc., Insulet Corporation. Advisory Panel; Self; Dexcom, Inc.. Speaker's Bureau; Self; Janssen Pharmaceuticals, Inc.. Advisory Panel; Self; Roche Diagnostics Corporation. M. Mocarski: Employee; Self; Novo Nordisk Inc.. Stock/Shareholder; Self; Novo Nordisk A/S. A. Schiffman: Employee; Self; Novo Nordisk Inc. Y. Handelsman: Consultant; Self; Amarin Corporation. Speaker's Bureau; Self; Amarin Corporation. Board Member; Self; American Association of Clinical Endocrinologists. Consultant; Self; Amgen Inc.. Research Support; Self; Amgen Inc.. Speaker's Bureau; Self; Amgen Inc.. Consultant; Self; AstraZeneca. Research Support; Self; AstraZeneca. Speaker's Bureau; Self; AstraZeneca. Research Support; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Bristol-Myers Squibb Company, Gan & Lee Pharmaceuticals. Consultant; Self; Intarcia Therapeutics, Inc., Janssen Pharmaceuticals, Inc.. Speaker's Bureau; Self; Janssen Pharmaceuticals, Inc.. Research Support; Self; Lexicon Pharmaceuticals, Inc.. Consultant; Self; Merck & Co., Inc.. Research Support; Self; Merck & Co., Inc.. Consultant; Self; Novo Nordisk Inc.. Research Support; Self; Novo Nordisk Inc.. Speaker's Bureau; Self; Novo Nordisk Inc., Regeneron Pharmaceuticals, Inc.. Consultant; Self; Sanofi. Research Support; Self; Sanofi. Speaker's Bureau; Self; Sanofi.

Background: This analysis aimed to understand differences in patient perspectives of their type 2 diabetes (T2DM) management and whether perspectives differed by patients’ current A1C. Methods: A cross-sectional, U.S. based web-survey was conducted among 618 adults with T2DM using basal insulin with or without oral antidiabetic medication which assessed perceptions, attitudes and behaviors associated with T2DM management. A1c levels were self-reported by patients as last communicated by their HCP, and confirmed with their HCP if necessary. Results: Patients with an A1c of ≥8% (n=193) were less likely than those with an A1c of 7-7.99% (n=194) or an A1c of <7% (n=231) to agree that they know how to control their T2DM (64% vs. 77% and 87%, p<0.05) and were less motivated to do so (59% vs. 74% and 80%, p<0.05). They were also less likely to report maintaining a healthy diet, being able to achieve their desired weight, and taking their T2DM medications as recommended. Patients with A1c ≥8% were also less likely to agree they have a good relationship with their HCP, kept their regularly scheduled appointments, and to find conversations with their HCP about T2DM control to be helpful. They were particularly less likely to feel their HCP could motivate them (63% vs. 84% and 81%, A1c 7-7.99% and A1c <7% respectively, p<0.05) and understood their life and challenges with T2DM (60% vs. 80% and 83%, p<0.05). Conclusions: In addition to differing perceptions of their ability to control their T2DM and struggling with adherence behaviors, patients with A1c ≥8% appear to have difficulty relating with their HCP. Although the directionality of the poorer HCP relationships and perceptions of control is unclear, better understanding the challenges faced by patients in controlling their T2DM may aid the development of successful strategies to help patients struggling with control. Disclosure M. Brod: Consultant; Self; Novo Nordisk A/S. K.J. Tomaszewski: Research Support; Self; Novo Nordisk Inc. A. Allen: Research Support; Self; Novo Nordisk Inc. D.F. Kruger: Research Support; Self; Dexcom, Inc.. Speaker's Bureau; Self; Dexcom, Inc.. Stock/Shareholder; Self; Dexcom, Inc.. Consultant; Self; Novo Nordisk Inc.. Speaker's Bureau; Self; Novo Nordisk Inc.. Research Support; Self; Novo Nordisk Inc.. Speaker's Bureau; Self; Eli Lilly and Company, Boehringer Ingelheim Pharmaceuticals, Inc.. Consultant; Self; Intarcia Therapeutics, Inc., Abbott. Research Support; Self; Sanofi. Consultant; Self; Sanofi. Research Support; Self; JAEB Center For Health Research. Consultant; Self; Janssen Pharmaceuticals, Inc.. Speaker's Bureau; Self; Janssen Pharmaceuticals, Inc.. Consultant; Self; AstraZeneca. Speaker's Bureau; Self; AstraZeneca. Research Support; Self; Hygieia, Lexicon Pharmaceuticals, Inc., National Institute of Diabetes and Digestive and Kidney Diseases. Speaker's Bureau; Self; Valeritas, Inc., Insulet Corporation. Consultant; Self; Insulet Corporation. Research Support; Self; Insulet Corporation. Consultant; Self; Merck & Co., Inc. M.K. Heile: Advisory Panel; Self; Novo Nordisk Inc.. Speaker's Bureau; Self; Novo Nordisk Inc., Insulet Corporation. Advisory Panel; Self; Dexcom, Inc.. Speaker's Bureau; Self; Janssen Pharmaceuticals, Inc.. Advisory Panel; Self; Roche Diagnostics Corporation. M. Mocarski: Employee; Self; Novo Nordisk Inc.. Stock/Shareholder; Self; Novo Nordisk A/S. A. Schiffman: Employee; Self; Novo Nordisk Inc. Y. Handelsman: Consultant; Self; Amarin Corporation. Speaker's Bureau; Self; Amarin Corporation. Board Member; Self; American Association of Clinical Endocrinologists. Consultant; Self; Amgen Inc.. Research Support; Self; Amgen Inc.. Speaker's Bureau; Self; Amgen Inc.. Consultant; Self; AstraZeneca. Research Support; Self; AstraZeneca. Speaker's Bureau; Self; AstraZeneca. Research Support; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Bristol-Myers Squibb Company, Gan & Lee Pharmaceuticals. Consultant; Self; Intarcia Therapeutics, Inc., Janssen Pharmaceuticals, Inc.. Speaker's Bureau; Self; Janssen Pharmaceuticals, Inc.. Research Support; Self; Lexicon Pharmaceuticals, Inc.. Consultant; Self; Merck & Co., Inc.. Research Support; Self; Merck & Co., Inc.. Consultant; Self; Novo Nordisk Inc.. Research Support; Self; Novo Nordisk Inc.. Speaker's Bureau; Self; Novo Nordisk Inc., Regeneron Pharmaceuticals, Inc.. Consultant; Self; Sanofi. Research Support; Self; Sanofi. Speaker's Bureau; Self; Sanofi.

Effects of switching to a titratable fixed-ratio combination of insulin glargine plus lixisenatide (iGlarLixi) in patients (pts) with T2D on GLP-1 RAs have been unknown. LixiLan-G (NCT02787551), a randomized, open-label, 26-week trial, compared switching to iGlarLixi vs. continued GLP-1 RA use in pts with T2D and HbA1c 7-9% despite receiving a maximum tolerated dose of a GLP-1 RA (liraglutide QD, exenatide BID, exenatide extended-release QW, albiglutide QW, or dulaglutide QW) with metformin ± pioglitazone ± SGLT2i. Treatment effects seen across baseline factors, such as BMI, GLP-1 RA type, and pioglitazone or SGLT2i use, were consistent with the primary analysis. This exploratory analysis examined HbA1c change at week 26 and documented symptomatic hypoglycemia in 26-week completers (modified ITT) by screening subgroup HbA1c levels (≤7.5%, >7.5-≤8%, and >8%). At week 26, mean HbA1c levels for iGlarLixi were 6.6%, 6.6%, and 6.9%, respectively, vs. 7.2%, 7.4%, and 7.5%, respectively, for GLP-1 RAs. Reductions were greater for iGlarLixi than for GLP-1 RAs in all subgroups (p<0.0001; Figure). Symptomatic hypoglycemia rates were low overall but higher with iGlarLixi than with GLP-1 RAs (Figure). In conclusion, in pts with T2D inadequately controlled on GLP-1 RA and OAD(s), iGlarLixi demonstrated additional glycemic benefit across a broad range of HbA1c levels. Disclosure S. Del Prato: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, GlaxoSmithKline plc., Merck Sharp & Dohme Corp., Novartis Pharmaceuticals Corporation, Novo Nordisk A/S, Sanofi, Servier, Takeda Pharmaceutical Company Limited. Board Member; Self; AstraZeneca. Research Support; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc. Speaker's Bureau; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Takeda Pharmaceutical Company Limited. L. Blonde: Consultant; Self; Gilead Sciences, Inc., Janssen Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk Inc., Sanofi US. Research Support; Self; Janssen Pharmaceuticals, Inc., Lexicon Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk Inc., Sanofi US. Speaker's Bureau; Self; Janssen Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi US. R.R. Henry: Advisory Panel; Self; Elcelyx Therapeutics, Inc. Consultant; Self; Diasome Pharmaceuticals, Inc., Ionis Pharmaceuticals, Inc. Employee; Self; Eli Lilly and Company. Research Support; Self; AstaReal, Hitachi, Ltd., Viacyte, Inc. Speaker's Bureau; Self; Servier. Other Relationship; Self; Abbott, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Intarcia Therapeutics, Inc., Johnson & Johnson, Lexicon Pharmaceuticals, Inc., Merck & Co., Inc., Sanofi-Aventis. V.R. Aroda: Consultant; Self; ADOCIA, AstraZeneca, Becton, Dickinson and Company, Novo Nordisk Inc., Sanofi, Zafgen, Inc. Employee; Spouse/Partner; Merck & Co., Inc. Research Support; Self; AstraZeneca, Calibra Medical, Eisai Inc., Janssen Research & Development, Novo Nordisk Inc., Sanofi, Theracos, Inc. N. Shehadeh: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi-Aventis. Speaker's Bureau; Self; Eli Lilly and Company, Merck Sharp & Dohme Corp. E. Niemoeller: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. E. Souhami: Employee; Self; Sanofi Research & Development. J. Wu: Employee; Self; Sanofi. X. Wang: Employee; Self; Sanofi Research & Development. C. Ji: Employee; Self; Sanofi Research & Development. J. Rosenstock: Research Support; Self; AstraZeneca, Bristol-Myers Squibb Company, Genentech, Inc., GlaxoSmithKline plc., Lexicon Pharmaceuticals, Inc., Melior Pharmaceuticals, Inc., Bukwang Pharm. Co., Ltd., Merck & Co., Inc., Oramed Pharmaceuticals, PegBio Co., Ltd., Pfizer Inc. Other Relationship; Self; Boehringer Ingelheim International GmbH, Eli Lilly and Company, Intarcia Therapeutics, Inc., Janssen Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi. Funding Sanofi

Fifty-Two-Week Efficacy and Safety of Sotagliflozin, a Dual SGLT1 and SGLT2 Inhibitor, as Adjunct Therapy to Insulin in Adults with Type 1 Diabetes (inTandem1)

Semaglutide, a glucagon-like peptide-1 analog for the once-weekly treatment of type 2 diabetes, provided superior glycemic control and weight loss (WL) vs. comparators in the SUSTAIN clinical trial program. This post hoc analysis assessed if WL was associated with patient-reported health-related quality of life (HRQoL) and treatment satisfaction improvements in SUSTAIN 2-5 and 7. Data for both semaglutide doses (0.5 and 1.0 mg) were pooled across trials (N=2,808). Change in HRQoL (Short Form-36 Health Survey version 2® [SF-36v2®] Physical Component Summary [PCS] and Mental Component Summary) and treatment satisfaction (Diabetes Treatment Satisfaction Questionnaire status version) scores were evaluated in subjects who achieved ≥5% and ≥10% WL vs. those who did not at end of treatment (30, 40 or 56 weeks). Overall, 51.0% and 17.4% of subjects achieved ≥5% and ≥10% WL with semaglutide. Significantly greater improvements in the overall PCS score and most of its components were reported in subjects achieving ≥5% and ≥10% WL vs. those not achieving these responses (Table). WL responses also correlated with overall treatment satisfaction and perception of hyperglycemia (Table). In conclusion, semaglutide-induced WL was associated with improvements in PCS domains of the SF-36v2®, overall treatment satisfaction and perception of hyperglycemia across the SUSTAIN 2-5 and 7 trials. Disclosure K.T. Uusinarkaus: Advisory Panel; Self; AstraZeneca, Janssen Pharmaceuticals, Inc., Novo Nordisk Inc. Speaker's Bureau; Self; Amarin Corporation, Amgen Inc., Regeneron Pharmaceuticals, Sanofi US. Stock/Shareholder; Self; Abbott, AbbVie Inc., Amarin Corporation, Pfizer Inc. H.W. Rodbard: Advisory Panel; Self; Bayer US, Janssen Pharmaceuticals, Inc., Lexicon Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk Inc., Sanofi. Consultant; Spouse/Partner; Eli Lilly and Company. Consultant; Self; Gan & Lee Pharmaceuticals. Research Support; Self; Lexicon Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi. Speaker's Bureau; Self; Merck & Co., Inc., Novo Nordisk Inc. L. Van Gaal: Advisory Panel; Self; Janssen Pharmaceuticals, Inc., Johnson & Johnson. Speaker's Bureau; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Sanofi, Servier. J.P. Wilding: Consultant; Self; Astellas Pharma Europe Ltd., AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, NAPP Pharmaceuticals Limited, Novo Nordisk A/S, Sanofi. Research Support; Self; AstraZeneca, Novo Nordisk A/S. Speaker's Bureau; Self; Eli Lilly and Company, WebMD. T. Hansen: None. A. Sandberg: Employee; Self; Novo Nordisk A/S. S. Tadayon: Employee; Self; Novo Nordisk A/S. M.J. Davies: Advisory Panel; Self; Eli Lilly and Company, Janssen Global Services, LLC., Novo Nordisk A/S, Sanofi-Aventis, Servier. Research Support; Self; Boehringer Ingelheim International GmbH, Novo Nordisk Foundation. Speaker's Bureau; Self; Boehringer Ingelheim International GmbH, Eli Lilly and Company, Novo Nordisk A/S, Sanofi-Aventis, Takeda Pharmaceutical Company Limited. Funding Novo Nordisk A/S